Dare Bioscience Investor Presentation Deck
Indication
Dosage &
Administration
Contraindications
Warnings &
Precautions
Adverse
Reactions
Drug Interactions
XACIATO Important Safety Information*
XACIATO (clindamycin phosphate) vaginal gel is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in
female patients 12 years of age and older.
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Administer one applicatorful (5 g of gel containing 100 mg of clindamycin) once intravaginally as a single dose at any time of the
day. Not for ophthalmic, dermal, or oral use.
XACIATO is contraindicated in patients with a history of hypersensitivity to clindamycin or lincomycin.
Clostridioides difficile-Associated Diarrhea (CDAD): Discontinue and evaluate if diarrhea occurs
Use with Polyurethane Condoms: Polyurethane condoms are not recommended during treatment with XACIATO or for 7 days
following treatment. During this time period, polyurethane condoms may not be reliable for preventing pregnancy or for protecting
against transmission of HIV and other sexually transmitted diseases. Latex or polyisoprene condoms should be used.
The most common adverse reactions reported in >2% of patients in the Phase 3 placebo-controlled trial and at a higher rate in the
XACIATO group than in the placebo group were vulvovaginal candidiasis and vulvovaginal discomfort.
Systemic clindamycin has neuromuscular blocking properties that may enhance the action of other neuromuscular blocking
agents. It should be used with caution in patients receiving such agents.
*See Full Prescribing Information at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215650sooolbl.pdf
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